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Effects of Tracheostomy Decannulation on Respiratory Function

Recruitingn/aAges 18 Years - anyAllCapital Medical University
NCT07191509 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This single-center prospective study enrolls adult patients with long-term tracheostomy who are ready for tube removal (decannulation). Twenty-four hours before decannulation, each participant will receive three physiologic tests-breathing through the tracheostomy tube, breathing with a one-way speaking valve, and breathing with the tube capped. Standard pulmonary-function and arterial-blood-gas measurements will be taken during each test and again 5 days after the tube is removed. The study compares these methods to identify which pre-decannulation test best predicts safe, successful decannulation and to describe the overall impact of tube removal on respiratory function.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥ 18 years. * Tracheostomised patient whose primary illness is stable and who is scheduled for elective decannulation in the rehabilitation unit. * Able to tolerate a one-way speaking valve for ≥ 4 h on the day before planned decannulation. * Capable of following instructions and completing bedside spirometry. * Patient (or legally authorised representative) has provided written informed consent. Exclusion Criteria: * No tracheostomy in place or requirement for re-intubation/re-cannulation after planned decannulation. * Inability to perform lung-function testing either via the tracheostomy tube or via the mouth/nose (e.g., severe upper-airway obstruction, facial deformity). * Unstable cardiopulmonary or neurological status that makes spirometry unsafe (e.g., ongoing myocardial ischemia, uncontrolled arrhythmia, severe agitation). * Any acute condition requiring isolation precautions that preclude study procedures. * Refusal or inability to sign informed consent. * Missing or incomplete key outcome data.
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What it tests

  • Speaking Valve ，Tracheostomy Tube Occlusion ，Tracheostomy Tube Ventilation
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Where

1 site
Beijing Rehabilitation Hospital, Capital Medical University
Beijing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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